In this article, the Food and Drug Administration has approved Novo Nordisk’s Ozempic for the treatment of chronic kidney disease in patients with Type 2 diabetes. This approval expands the use of the injection in the U.S., where it is already widely used to treat Type 2 diabetes. Ozempic can now be used to reduce the risk of kidney disease progression, kidney failure, and death from cardiovascular disease in patients with both chronic kidney disease and diabetes.
This decision has the potential to change how doctors manage patients with chronic kidney disease, a condition characterized by a gradual decline in kidney function and a leading cause of death in the U.S. Approximately 37 million American adults are living with chronic kidney disease, according to Novo Nordisk. Diabetes is a significant risk factor for kidney disease, with around 40% of Type 2 diabetes patients affected. This condition can lead to additional health issues such as an increased risk of cardiovascular problems and death.
Stephen Gough, Novo Nordisk’s global chief medical officer, highlighted the progressive nature of chronic kidney disease, emphasizing the relentless decline in renal function over time. When the disease advances to end-stage kidney disease, patients often require long-term dialysis or a kidney transplant, both of which are burdensome. The approval of Ozempic also underscores the broader health benefits of GLP-1 drugs beyond managing blood sugar levels and appetite suppression.
Clinical trials showed that Ozempic reduced the risk of severe kidney outcomes by 24% in diabetic patients with chronic kidney disease compared to a placebo. Patients on Ozempic experienced slower kidney function decline, an 18% drop in major cardiovascular events, a 20% decrease in all-cause mortality, and a 29% reduction in cardiovascular-related deaths. The drug also demonstrated a lower rate of serious adverse effects compared to the placebo group.
The approval in the U.S. follows a similar approval by EU regulators in December. Novo Nordisk’s decision to end a phase three trial early due to positive results caused shares of kidney dialysis companies to drop significantly. The trial, known as FLOW, involved approximately 3,500 patients with diabetes and moderate to severe chronic kidney disease.
Novo Nordisk’s drugs with semaglutide as the active ingredient, including Ozempic, Wegovy, and Rybelsus, were selected by the Biden administration for Medicare drug price negotiations. The approval of Ozempic for chronic kidney disease treatment coincides with increased competition from Eli Lilly and efforts by Novo Nordisk to expand insurance coverage for Wegovy, a weight loss drug approved for reducing the risk of major cardiovascular events. Wegovy is also being studied as a potential treatment for fatty liver disease.
